FDA 510(k)

維洛菲克斯TLIF金屬支架

K 號：K183243 · 2019-07-10

決定日期2019-07-10

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Velofix TLIF Cage is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K183243. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Velofix TLIF Cage?

Velofix TLIF Cage is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is U&I Corporation. The 510(k) number is K183243.

When did Velofix TLIF Cage receive FDA 510(k) clearance?

Velofix TLIF Cage received FDA 510(k) clearance on 2019-07-10, under 510(k) number K183243.

Who is the listed applicant for Velofix TLIF Cage?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velofix TLIF Cage?

The FDA product code for Velofix TLIF Cage is MAX.

其他以 U&I Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K220147Aspiron S ACP 系統 K210573維洛菲克斯SA頸椎籠 K190067維洛菲克斯內固定融合系統 K190053SECULOK™ ACP 系統 K181824CBT 螺釘固定系統 K183383ANAX™ OCT 脊柱系統

查看所有 16 項裝置 →

相關器械（代碼：MAX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261049SCALA® TLSpineart SA K261430TruLift可擴展系統Life Spine, Inc.K253011Catalyft PL 可擴展椎間體系統Medtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L脊椎系統Medtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics Corporation K253151Fule間體融合籠架系統Beijing Fule Science & Technology Development Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。